6460 - Senior CQV Engineer / Senior Validation Engineer
$70,491–$109,900 year
On-siteDurham, North Carolina, United States
Job Summary
Design validation plans, conduct impact and risk assessments, and execute engineering studies for critical process parameters. Author and edit technical commissioning, qualification, and validation documentation while running test scripts and documenting results for pharmaceutical manufacturing compliance. Maintain detailed records of change control activities and ensure adherence to project schedules. Complete user interface testing, software verification, and alarm testing on automated systems, making recommendations for design modifications based on test outcomes. Work onsite in the Raleigh/Durham metropolitan area with 10-50% potential travel.
Required Qualifications
- Must be able/willing to work onsite in the Raleigh/Durham metropolitan area
- Must be willing to meet potential future travel requirements (10-50%)
- Bachelor's Degree or equivalent required
- 4 - 6 years of demonstrated role relevant experience
- Demonstrated experience in leading CQV activities specific to pharmaceutical manufacturing requirements
- Experience in GMP regulated environment
- Capable of working on assigned tasks without mentorship
Desired Qualifications
- Ability to mentor and guide less experienced team members
- Ability to communicate effectively with clients
- Proven ability to identify areas of business expansion and report to management team for follow-up
- Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
- Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
- Ability to work as part of a team
- Strong problem-solving and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- GMP and Good Documentation Practice
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
- Basic skills with EXCEL and PowerPoint
- Strong interpersonal skills and clear communication capabilities
- Experience with and tolerance for high levels of challenge and change
- Proven attention to detail and organization in project work
- General understanding of capital equipment implementation and process knowledge
- Understanding validation documents, URS, IQ, OQ, PQ
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